[18F]AlF-NOTA-octreotide PET/MRI in Carotid Artery Disease

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jul 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of imaging test called [¹⁸F]AlF-NOTA-octreotide PET/MRI to see if it can help doctors understand inflammation (swelling and irritation) in the arteries of the neck, specifically where plaque builds up. This plaque can narrow the arteries and increase the risk of stroke or mini-strokes (called TIAs). The goal is to find out if this imaging test can predict who is more likely to have another stroke or related problems in the future by measuring how much the tracer shows up in the arteries.

People who might join this study are adults over 18 who have recently had an ischemic stroke or a high-risk TIA affecting the carotid artery (a major artery in the neck) and have at least 30% narrowing of that artery. Participants will have the PET/MRI scan within 21 days of their stroke or TIA and will then be followed up by phone at 3 months, 1 year, and 3 years to check on their health. The study excludes people who are pregnant, have certain types of strokes, serious other illnesses, recent artery surgery or stenting, kidney problems, or cannot have an MRI. This study could help improve how doctors predict and prevent future strokes by better understanding artery inflammation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant is aged over 18 years.
• • 2. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedure
• • 3. CT angiography imaging at baseline should be available as part of routine care
• • 4. Participant is diagnosed with a recent ischemic stroke or high-risk TIA (ABCD2 ≥ 4) in the carotid artery territory and ≥ 30% carotid artery stenosis. The stroke/TIA has occurred no more than 21 days prior to tracer administration.
• Exclusion Criteria:
• • 1. Female who is pregnant or breast-feeding
• • 2. Participants with a cardio-embolic stroke, small vessel stroke or other defined stroke etiology according to the TOAST classification (23)
• • 3. Participant has a previous or ongoing recurrent or chronic disease at high risk to interfere with the performance or evaluation of the trial, according to the judgment of the investigator
• • 4. Participants treated with carotid endarterectomy or carotid artery stenting within the past year
• • 5. Subject has a contra-indication for or cannot tolerate MR scanning
• • 6. Subject has an impaired renal function estimated glomerular filtration rate (eGFR) \< 40 ml/min/1.73m² (the last known value may not date from more than 3 months prior to the study PET/MR; if not available a blood analysis may be performed as part of the trial)
• • 7. Concurrent treatment with corticosteroids and/or somatostatin analogues
• • 8. Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator